- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178421
Computerized Eye-tracking Attention Training for Children With Special Needs
November 25, 2019 updated by: Professor Chan Sui-yin Agnes, Chinese University of Hong Kong
Children with special needs (e.g.
autistic spectrum disorder, attention deficit hyperactivity disorder) are found to have sustained attention problems.
Several behavioral interventions have been carried out in the past to improve this situation.
However, these interventions are often involved a high administration cost.
Recently, researchers have been focusing on training the eye gaze fixation using the eye-tracking training games, as some of the research studies reported a correlation between atypical eye gaze patterns with poor sustained attention.
The objective of the present study is to evaluate the effectiveness of a computerized eye-tracking attention training.
Two batches of 48 primary school students will be recruited from email and the subject pool of the Department of Psychology of The Chinese University of Hong Kong.
Participants are dividedly randomly and equally into either intervention or control group.
Participants in both groups will undergo pre- and post-assessments measuring the executive function and attention before and after the intervention, respectively.
However, there will be eight eye-tracking training sessions for the intervention group, but only the assessments are received in the control group.
It is hypothesized that after the training, the performance of the training games and assessments will improve, indicated by increasing accuracy rates, as well as the reaction time of the tasks.
The results would provide important information on the value of computerized eye gaze training and would guide the direction of interventions that target on improving the sustained attention and impulse control of children with special needs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a total of 96 primary school children (aged between 6 to 12 years) with special needs, defined by psychological disorders such as ASD, ADHD, ADD, and Dyslexia
Exclusion Criteria:
- Children with mental retardation will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental Group
A computerized eye -tracking program training the eye gaze fixation with the target to improve impulse control and sustained attention of children with special needs
|
Eye-gaze fixation computer based training program
|
|
PLACEBO_COMPARATOR: Control Group
Computerized program
|
Pac-Man, Zookeeper, Tetris
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flanker Inhibitory Control and Attention Test (Cognitive Test)
Time Frame: through study completion, an average of 2 year
|
flanker inhibitory control and attention test to assess their attention
|
through study completion, an average of 2 year
|
|
Dimensional Change Card Sort Test (Psychological Test Battery)
Time Frame: through study completion, an average of 2 year
|
the Dimensional Change Card Sort Test to measure executive function
|
through study completion, an average of 2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2018
Primary Completion (ACTUAL)
August 30, 2019
Study Completion (ACTUAL)
September 10, 2019
Study Registration Dates
First Submitted
November 22, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (ACTUAL)
November 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 26, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0298
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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